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DIHYDROERGOTAMINE MESYLATE Recall D-1011-2022

Description: Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules, Rx only, Manufactured for: Perrigo, Minneapolis, MN, NDC 0574-0850-10

DIHYDROERGOTAMINE MESYLATE Recall D-1011-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1011-2022
Event ID89646
BrandDIHYDROERGOTAMINE MESYLATE
Generic NameDIHYDROERGOTAMINE MESYLATE
ManufacturerDIHYDROERGOTAMINE MESYLATE
Original Package?1
Active SubstanceDIHYDROERGOTAMINE MESYLATE
Drug RouteINTRAMUSCULAR
DistributionUSA nationwide.
Quantity1 carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0574-0850
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier81AXN7R2QT
Drug Application NumberANDA040475
Structured Product Labeling (SPL ID)bddefdbb-8713-456f-993f-458ddd94803f
Structured Product Labeling (SPL Set ID)111f628a-7e1e-4d47-8ac1-f898cbfc9b74
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